Submassive Pulmonary EmbolismSPEARNCT01899339
Long Term Effects of Treating Submassive Pulmonary Embolism With Ultra-sound Accelerated Thrombolysis
An observational study of Submassive Pulmonary Embolism, run by Corewell Health West at 1 site in United States.
Trial summary
Patients with Submassive Pulmonary Embolism treated with ultra-sound therapy will have an improved right ventricular function 72 hours post treatment. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Submassive Pulmonary Embolism
- What is being tested?
- submassive PA treatment with Ekosonic endo device
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- May 2013to Feb 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patient presenting to the Emergency Department with submassive pulmonary hypertension over the age of 18.
Who may be able to join
- Patients with acute (< or = 14 days)symptomatic pulmonary embolism by CT Angiogram of the thorax with embolus involving at least one main or lower lobe pulmonary artery and RV:LV ratio > 0.9
Who cannot join
- age > 80
- Recent thrombolytic therapy (with in 4 days)
- Active bleeding or know bleeding diathesis
- Known coagulopathy (including treatment with vitamin K antagonists) INR > 3 and/or PTT > 50
- Thrombocytopenia (PLT cound < 100,000)
- History of any intracranial or intraspinal surgery, trauma or bleed
Show all 19Show fewer
- Intracranial neoplasms, AVM, or aneurysm
- Recent (< 1 month) GI bleed
- Recent (< 3 months) internal eye surgery or hemorrhagic retinopathy
- Recent (< 7 days) major surgery, trauma, or obstetrical delivery
- Renal insufficiency with eGFR < 45 ml/min
- Known allergy, hypersensitivity, or thrombocytopenia from heparin or tPA
- Hemodynamic instability defined as need for cardiopulmonay resuscitation, Systolic BP > 90 mm Hg for > 15 min or need for pressor agents to maintain BP > 90.
- Severe Hypertension (sustained systolic > 180 mm Hg or diastolic > 90 mm Hg.
- Pregnant patients
- known right to left shunt
- Large (>10 mm)intracardiac thrombus
- Use of thrombolytics or glycoprotein IIb/IIIa antangonists within 3 days of inclusion.
- Life expectancy < 30 days
Trial locations and contacts
1 site in 1 country.
United States1 site
Spectrum Health Hospitals
Grand Rapids, Michigan, 49503
About this study
Official title: Submassive Pulmonary Embolism Treatment With Ultrasound-Accelerated Thrombolysis
Patients with Submassive Pulmonary Embolism treated with ultra-sound therapy will have an improved right ventricular function 72 hours post treatment.
- Conditions
- Submassive Pulmonary Embolism
- Being tested
- submassive PA treatment with Ekosonic endo device
- Keywords
- submassive pulmonary embolism, Ultrasonic energy, Ekosonic Endovascular Device, RV:LV function after Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
submassive PA treatment with Ekosonic endo deviceOther
Also called Ekosonic Endovascular Device
Ultra Sound energy along with tPA to treat submassive pulmonary embolism
| Study group | Role | What they receive |
|---|---|---|
| pulmonary embolism | patients with submassive pulmonary embolism Receives: Other: submassive PA treatment with Ekosonic endo device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Right Ventricular:Left Ventricular ratio
Treatment will show improved Right Ventricular:Left Ventricular ratio at 72 hours post.
Measured: baseline to 72 hours post
Secondary outcomes (1)
recurrent pulmonary embolism
Will assess whether a recurrent Pulmonary Embolism has happened at 30 day post procedure or earlier
Measured: 30 days post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2013 (estimated)
- Study startMay 2013
- Primary completionFeb 2019
- Study completionFeb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Submassive Pulmonary EmbolismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corewell Health West
- Sponsor type
- University, hospital or other
- Collaborators
- EKOS Corporation
- Responsible party
- Principal investigator, Michael F Knox, MD, Corewell Health West
- Investigators
- Michael Knox, MD, Principal investigator, Spectrum Health Hosptials and ARS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01899339
- Sponsor's protocol ID
- 2013-069
- Other IDs
- Ekos
- Acronym
- SPEAR
- Status last verified
- Jul 2023
- First submitted
- 10 Jul 2013
- Last updated
- 18 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Submassive Pulmonary Embolism Treatment With Ultrasound-Accelerated Thrombolysis
- ClinicalTrials.gov ID
- NCT01899339
- Acronym / sponsor ID
- SPEAR / 2013-069
- Conditions
- Submassive Pulmonary Embolism
- Keywords
- submassive pulmonary embolism, Ultrasonic energy, Ekosonic Endovascular Device, RV:LV function after Pulmonary Embolism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Corewell Health WestUniversity, hospital or other
- Collaborators
- EKOS Corporation
- Study start
- May 2013
- Primary completion
- Feb 2019 (actual)
- Study completion
- Feb 2019 (actual)
- First posted
- 15 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients with Submassive Pulmonary Embolism treated with ultra-sound therapy will have an improved right ventricular function 72 hours post treatment.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pulmonary embolism | – | Other: submassive PA treatment with Ekosonic endo devicepatients with submassive pulmonary embolism |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patient presenting to the Emergency Department with submassive pulmonary hypertension over the age of 18.
Key inclusion criteria (1 listed)
- Patients with acute (< or = 14 days)symptomatic pulmonary embolism by CT Angiogram of the thorax with embolus involving at least one main or lower lobe pulmonary artery and RV:LV ratio > 0.9
Key exclusion criteria (19 listed)
- age > 80
- Recent thrombolytic therapy (with in 4 days)
- Active bleeding or know bleeding diathesis
- Known coagulopathy (including treatment with vitamin K antagonists) INR > 3 and/or PTT > 50
- Thrombocytopenia (PLT cound < 100,000)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| submassive PA treatment with Ekosonic endo deviceAlso: Ekosonic Endovascular DeviceUltra Sound energy along with tPA to treat submassive pulmonary embolism | Other | pulmonary embolism |
Primary outcome
Change in Right Ventricular:Left Ventricular ratio
Time frame: baseline to 72 hours post
Treatment will show improved Right Ventricular:Left Ventricular ratio at 72 hours post.
1 secondary outcome
recurrent pulmonary embolism
Time frame: 30 days post procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2023.
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Pulmonary Embolism
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Knox, MD principal investigator
Spectrum Health Hosptials and ARS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Submassive Pulmonary Embolism, run by Corewell Health West at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Right Ventricular:Left Ventricular ratio (time frame: baseline to 72 hours post). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2023.